The following data is part of a premarket notification filed by Shotwell & Carr, Inc. with the FDA for Smart Wave Gs100.
| Device ID | K950617 |
| 510k Number | K950617 |
| Device Name: | SMART WAVE GS100 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | SHOTWELL & CARR, INC. 3003 LBJ FREEWAY, SUITE 100 Dallas, TX 75234 -7755 |
| Contact | Stan E Tillman |
| Correspondent | Stan E Tillman SHOTWELL & CARR, INC. 3003 LBJ FREEWAY, SUITE 100 Dallas, TX 75234 -7755 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-10 |
| Decision Date | 1995-10-13 |